Heart Failure Clinical Trial

A Proof of Concept and Dose-finding Study of XXB750 in Patients With Heart Failure

Summary

This is a multicenter, randomized, placebo- and active-controlled, parallel-group, 24-week trial to investigate the efficacy, safety, and tolerability of XXB750 in participants with HFrEF/HFmrEF.

View Full Description

Full Description

Eligible participants will be randomized to receive either subcutaneous (s.c.) XXB750 or placebo; or sacubitril/valsartan for 16 weeks, and then followed-up for 8 weeks

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Current symptom(s) of HF NYHA class II-III and LVEF < 50%
Elevated NT-proBNP levels at screening.
Receiving standard of care background HF therapy.

Exclusion Criteria:

Current acute decompensated HF or hospitalization for HF within 3 months prior to screening.
Current symptomatic hypotension (for example dizziness/presyncope).
K+ > 5.4 mmol/L at screening
eGFR < 30 mL/min/1.73m2 at screening

Other protocol-specific criteria may apply.

Study is for people with:

Heart Failure

Phase:

Phase 2

Estimated Enrollment:

720

Study ID:

NCT06142383

Recruitment Status:

Recruiting

Sponsor:

Novartis Pharmaceuticals

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There are 101 Locations for this study

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SEC Clinical Research Research
Dothan Alabama, 36305, United States More Info
Olga Stafford
Contact
[email protected]
Robert I Garver
Principal Investigator
Heart Center Research Llc .
Huntsville Alabama, 35801, United States More Info
Hannah Winkles
Contact
256-519-8255
[email protected]
Kaushik K Jain
Principal Investigator
Pima Heart And Vascular Clin Rch Research
Tucson Arizona, 85704, United States More Info
Natheer Aljanabi
Contact
[email protected]
Ajay Tuli
Principal Investigator
Nature Coast Clinical Research LLC
Inverness Florida, 34452, United States More Info
Donald Bowen
Contact
352-341-2100
[email protected]
Rafik Abadier
Principal Investigator
Jacksonville Ctr for Clin Rea Main Centre
Jacksonville Florida, 32216, United States More Info
Robyn Pelletier
Contact
904-730-0101
[email protected]
Michael J Koren
Principal Investigator
East Coast Institute for Research East Coast Inst for Res ECIR
Jacksonville Florida, 32223, United States More Info
Leann Petschonek
Contact
[email protected]
Jerry W Chandler
Principal Investigator
Inpatient Research Clinical LLC
Miami Lakes Florida, 33014, United States More Info
Contact
786-502-4303
Alexis Gutierrez
Principal Investigator
Miami Clinical Research .
Miami Florida, 33155, United States More Info
Mariana Wefer
Contact
[email protected]
Keila Hoover
Principal Investigator
Ormond Beach Clinical Research
Ormond Beach Florida, 32174, United States More Info
Taylor Lenholt
Contact
[email protected]
Dinesh Arab
Principal Investigator
St Johns Center Research
Ponte Vedra Florida, 32801, United States More Info
Kimberly McKenzie
Contact
[email protected]
Ameeth Vedre
Principal Investigator
East Coast Inst for Research LLC
Saint Augustine Florida, 32086, United States More Info
Ferris George
Principal Investigator
Cardiology Partners Clinical Research Institute
Wellington Florida, 33449, United States More Info
Dani Vargas
Contact
561-537-4778
[email protected]
Jean Foucauld
Principal Investigator
American Clinical Trials
Acworth Georgia, 30101, United States More Info
Iasia Williams
Contact
[email protected]
Chinedu Nweke
Principal Investigator
The Research Group Lewis Hargett Circle
Lexington Kentucky, 40503, United States More Info
Jennifer Nichols
Contact
[email protected]
Justin Arambasick
Principal Investigator
Heart Clinic of Hammond .
Hammond Louisiana, 70403, United States More Info
Juliana Roberts
Contact
985-269-7106
[email protected]
Ghiath Mikdadi
Principal Investigator
Grace Research Llc .
Shreveport Louisiana, 71101, United States More Info
Taylor Moore
Contact
318-626-5180
[email protected]
Anil Chhabra
Principal Investigator
Anderson Medical Research Main Center
Fort Washington Maryland, 20744, United States More Info
Felton Anderson
Principal Investigator
Revival Research Institute .
Troy Michigan, 48084, United States More Info
Khalida Makin
Contact
[email protected]
Qaiser Shafiq
Principal Investigator
Troy Internal Medicine Research .
Troy Michigan, 48098, United States More Info
Megan Nicholas
Contact
[email protected]
Neil J. Fraser
Principal Investigator
Fairview Health Services St Johns
Saint Paul Minnesota, 55103, United States More Info
Alexandra Clute
Contact
[email protected]
Les Forgosh
Principal Investigator
St Louis Heart and Vascular .
Saint Louis Missouri, 63136, United States More Info
Amber Mica
Contact
314-741-0911
[email protected]
Mohammad Tahir
Principal Investigator
Aultman Hospital
Canton Ohio, 44710, United States More Info
Ataul Qureshi
Principal Investigator
NexGen Research
Lima Ohio, 45805, United States More Info
Nneamaka Ezema
Contact
260-300-6394
[email protected]
Nonso Ezema
Principal Investigator
Clinical Research of Rock Hill
Rock Hill South Carolina, 29732, United States More Info
Treacy McTier
Contact
803-251-9502
[email protected]
Michael Denenberg
Principal Investigator
Tennessee Center For Clinical Trials .
Tullahoma Tennessee, 37388, United States More Info
Bethany Jernigan
Contact
931-461-2663
[email protected]
Dinesh Gupta
Principal Investigator
Cypress Heart and Vascular Center
Cypress Texas, 77429, United States More Info
Contact
832-688-8400
Fadi Alameddine
Principal Investigator
John Peter Smith Hospital
Fort Worth Texas, 76104, United States More Info
Whitney Cromartie
Contact
[email protected]
Sandeep Kamath
Principal Investigator
Grace Research .
Marshall Texas, 75670, United States More Info
Kristen Terry
Contact
318-626-5180
[email protected]
William Eaves
Principal Investigator
Dominion Medical Associates
Richmond Virginia, 23219, United States More Info
Contact
804-836-6540
Richard A Jackson
Principal Investigator
Universal Research Group LLC Suite 202
Tacoma Washington, 98405, United States More Info
Iliana Mcdaniel
Contact
253-882-1070
[email protected]
Sabrina Benjamin
Principal Investigator
Novartis Investigative Site
Blagoevgrad , 270 0, Bulgaria
Novartis Investigative Site
Gabrovo , 5300, Bulgaria
Novartis Investigative Site
Kyustendil , 2500, Bulgaria
Novartis Investigative Site
Pleven , 5800, Bulgaria
Novartis Investigative Site
Plovdiv , 4002, Bulgaria
Novartis Investigative Site
Sofia , 1233, Bulgaria
Novartis Investigative Site
Sofia , 1510, Bulgaria
Novartis Investigative Site
Sofia , 1709, Bulgaria
Novartis Investigative Site
Stara Zagora , 6000, Bulgaria
Novartis Investigative Site
Varna , 9010, Bulgaria
Novartis Investigative Site
Guangzhou Guangdong, 51051, China
Novartis Investigative Site
Herlev , DK 27, Denmark
Novartis Investigative Site
Hvidovre , 2650, Denmark
Novartis Investigative Site
Roskilde , 4000, Denmark
Novartis Investigative Site
Beziers Cedex , 34525, France
Novartis Investigative Site
Montpellier , 34295, France
Novartis Investigative Site
Rouen , 76031, France
Novartis Investigative Site
Toulouse 4 , 31054, France
Novartis Investigative Site
Essen Nordrhein Westfalen, 45355, Germany
Novartis Investigative Site
Dresden Sachsen, 01099, Germany
Novartis Investigative Site
Berlin , 10787, Germany
Novartis Investigative Site
Coburg , 96450, Germany
Novartis Investigative Site
Frankfurt , 60594, Germany
Novartis Investigative Site
Gladbeck , 45968, Germany
Novartis Investigative Site
Kiel , 24105, Germany
Novartis Investigative Site
Koeln , 51065, Germany
Novartis Investigative Site
Ludwigshafen , 67063, Germany
Novartis Investigative Site
Ludwigshafen , 67067, Germany
Novartis Investigative Site
Schwaebisch Hall , 74523, Germany
Novartis Investigative Site
Stuttgart , 70376, Germany
Novartis Investigative Site
Ancona AN, 60128, Italy
Novartis Investigative Site
Bergamo BG, 24128, Italy
Novartis Investigative Site
Brescia BS, 25123, Italy
Novartis Investigative Site
Cona FE, 44100, Italy
Novartis Investigative Site
Messina ME, 98125, Italy
Novartis Investigative Site
Milano MI, 20138, Italy
Novartis Investigative Site
Pisa PI, 56126, Italy
Novartis Investigative Site
Roma RM, 00161, Italy
Novartis Investigative Site
Trieste TS, 34149, Italy
Novartis Investigative Site
Koriyama Fukushima, 963-8, Japan
Novartis Investigative Site
Maebashi city Gunma, 371 8, Japan
Novartis Investigative Site
Kawasaki-city Kanagawa, 216-8, Japan
Novartis Investigative Site
Sagamihara Kanagawa, 252-0, Japan
Novartis Investigative Site
Matsumoto Nagano, 390-8, Japan
Novartis Investigative Site
Kawaguchi-city Saitama, 333-0, Japan
Novartis Investigative Site
Hachioji-city Tokyo, 192-0, Japan
Novartis Investigative Site
Itabashi-ku Tokyo, 173-8, Japan
Novartis Investigative Site
Lisboa , 1495 , Portugal
Novartis Investigative Site
Lisboa , 1500 , Portugal
Novartis Investigative Site
Vila Nova De Gaia , 4434 , Portugal
Novartis Investigative Site
Presov Slovak Republic, 080 0, Slovakia
Novartis Investigative Site
Kosice , 040 0, Slovakia
Novartis Investigative Site
Nitra , 949 0, Slovakia
Novartis Investigative Site
Huelva Andalucia, 21005, Spain
Novartis Investigative Site
Malaga Andalucia, 29010, Spain
Novartis Investigative Site
Sevilla Andalucia, 41014, Spain
Novartis Investigative Site
Utrera Andalucia, 41710, Spain
Novartis Investigative Site
Valencia Comunidad Valenciana, 46010, Spain
Novartis Investigative Site
Santiago De Compostela Galicia, 15706, Spain
Novartis Investigative Site
El Palmar Murcia, 30120, Spain
Novartis Investigative Site
Alicante , 03700, Spain
Novartis Investigative Site
Las Palmas de Gran Canaria , 35010, Spain
Novartis Investigative Site
Madrid , 28034, Spain
Novartis Investigative Site
Madrid , 28040, Spain
Novartis Investigative Site
Madrid , 28041, Spain
Novartis Investigative Site
Madrid , 28222, Spain
Novartis Investigative Site
Valencia , 46026, Spain
Novartis Investigative Site
Kaohsiung , 80756, Taiwan
Novartis Investigative Site
Taichung , 40447, Taiwan
Novartis Investigative Site
Tainan , 71004, Taiwan
Novartis Investigative Site
Taipei , 11217, Taiwan

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Phase:

Phase 2

Estimated Enrollment:

720

Study ID:

NCT06142383

Recruitment Status:

Recruiting

Sponsor:


Novartis Pharmaceuticals

How clear is this clinincal trial information?

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